(171 days)
Not Found
No
The document describes a mechanical hip replacement system and its components, with no mention of software, algorithms, or AI/ML capabilities. The performance studies listed are mechanical tests.
Yes
The device is indicated for total hip replacement to treat various degenerative joint diseases and fractures, which involves therapeutic intervention.
No
This device is a total hip replacement system, indicated for various hip conditions and revision surgeries. It is an implant used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a modular hip replacement system with various components, including liners, femoral heads, and acetabular cups, which are physical hardware components. The performance studies also describe testing on physical test units.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a hip replacement system (stems, cups, liners, heads). These are physical implants used in surgery.
- Performance Studies: The performance studies listed are related to the mechanical and material properties of the implant (wear, fatigue, range of motion, etc.), which are relevant to the function and durability of a surgical device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- · Rheumatoid arthritis;
· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
- Revision of previously failed total hip arthroplasty.
The EcoFit® Hip Stem and EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.
Product codes (comma separated list FDA assigned to the subject device)
LZO, OQI
Device Description
The EcoFit® Vit E Acetabular System is a line extension of EcoFit® Hip System, a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The EcoFit® Vit E Acetabular System adds additional liners, CoCr femoral heads, and Biolox® delta heads to the currently cleared system. Additionally, Vit E liners are added as compatible components in the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary testing has been performed for the worst-case configuration of the EcoFit® Vit E Acetabular System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the EcoFit® Acetabular System was characterized through the following tests:
- Modular Disassembly ●
- Normal Wear
- Abrasive Wear
- Impingement
- Range of Motion ●
- UHMWPE Particle Analysis ●
- UHMWPE Characterization ●
- Ceramic Burst ●
- Ceramic Axial Fatigue ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K163577, K091508, K042344, K061699, K141972, K171181, K142119, K123392
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 20, 2018
implantcast Gmbh % Dave Mcgurl Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001
Re: K180263
Trade/Device Name: EcoFit Vit E Acetabular System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, OQI Dated: June 21, 2018 Received: June 22, 2018
Dear Dave Mcgurl:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180263
Device Name EcoFit® Vit E Acetabular System
Indications for Use (Describe) The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- · Rheumatoid arthritis;
· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
- Revision of previously failed total hip arthroplasty.
The EcoFit® Hip Stem and EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
5. 510(k) Summary
| Device Trade Name: | EcoFit® Vit E Acetabular System |
|---|---|
| Manufacturer: | implantcast GmbH |
| Lueneburger Schanze 26 | |
| 21614 Buxtehude | |
| Germany | |
| Contact: | Ms. Juliane Höppner |
| Phone: +49 4161 744-135 | |
| Fax: +49 4161 744-200 | |
| j.hoeppner@implantcast.de | |
| Prepared by: | Mr. Dave McGurl |
| Director, Regulatory Affairs | |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: 202.552.5797 | |
| Fax: 202.552.5798 | |
| dmcgurl@mcra.com | |
| Date Prepared: | July 12, 2018 |
| Classification: | 21 CFR 888.3353 |
| Class: | II |
| Product Codes: | LZO, OQI |
| Primary Predicate Device: implantcast GmbH EcoFit® Hip System (K163577) | |
| Additional Predicates: | Zimmer, Inc. Continuum and Trilogy Cups (K091508) |
| Aesculap, Inc. Acetabular Cups Plasmacup® SC (K042344) | |
| Aesculap, Inc. Plasmacup® NSC (K061699) | |
| Total Joint Orthopedics, Inc. | |
| Klassic HD Acetabular Insert With E-Link Poly (K141972) | |
| MicroPort Orthopedics, Inc. PROCOTYL® PRIME E- | |
| CLASS™ XLPE Liner (K171181) | |
| MicroPort Orthopedics, Inc. PROCOTYL® L-O Acetabular | |
| System (K142119) | |
| Zimmer GmbH Avenir Muller Stem (K123392) |
4
Indications for Use:
The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis:
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the ● proximal femur with head involvement that are unmanageable by other techniques: and
- . Revision of previously failed total hip arthroplasty.
The EcoFit® Hip Stem and EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.
Device Description:
The EcoFit® Vit E Acetabular System is a line extension of EcoFit® Hip System, a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The EcoFit® Vit E Acetabular System adds additional liners, CoCr femoral heads, and Biolox® delta heads to the currently cleared system. Additionally, Vit E liners are added as compatible components in the system.
Performance Testing:
All necessary testing has been performed for the worst-case configuration of the EcoFit® Vit E Acetabular System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the EcoFit® Acetabular System was characterized through the following tests:
- Modular Disassembly ●
- Normal Wear
- Abrasive Wear
- Impingement
- Range of Motion ●
- UHMWPE Particle Analysis ●
- UHMWPE Characterization ●
- Ceramic Burst ●
- Ceramic Axial Fatigue ●
Substantial Equivalence:
The EcoFit Vit E Acetabular System is substantially equivalent in materials, indications, function and/or performance to the predicate devices (K163577, K091508, K042344, K061699, K141972, K171181, K142119, and K123392).